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Study of the Collaborative Life Skills Program

Primary Purpose

Attention Deficit Hyperactivity Disorder Symptoms

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Collaborative Life Skills Intervention (CLS)

Business As Usual

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder Symptoms focused on measuring Attention Deficit Hyperactivity Disorder, Psychosocial Intervention, Behavioral Intervention, School-home collaborative intervention

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Attending a participating school and in 2-5th grade
Referral by LSP as a child with apparent ADHD-related problems
≥ 6 symptoms (item score ≥ 2) of Inattention or Hyperactivity-Impulsivity on the pooled parent and teacher Child Symptom Inventory
≥ 3 on the Impairment Rating Scale by parent and teacher (cross-situational impairment)
FSIQ or VIQ ≥ 80 (necessary for cognitive demands of the child skills curriculum)
Caretaker consents to participate in treatment, child assents to participate

Exclusion Criteria:

Presence of conditions that are incompatible with this study's treatment.
severe visual or hearing impairment,
severe language delay,
psychosis,
pervasive developmental disorder
Parent or child does not read or speak English or does not read or speak Spanish for our Spanish language implementation of CLS (inability to complete assessment measures or participate in group treatments).
Child is in an all-day special education classroom (children in these classrooms are frequently receiving intensive behavior modification programs such that the intervention would be expected to require modification for use in these settings)
Children taking psychotropic medication for any reason other than to treat ADHD
Children planning to change (start or stop) psychotropic medication
Children who have changed a regimen of psychotropic medication (started or stopped) within 30 days prior to screening

Sites / Locations

University of California San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Business as Usual (BAU)

Collaborative Life Skills Intervention (CLS)

Arm Description

This group receives services as usual in their schools. They will receive the intervention after follow-up measures are gathered.

CLS is a 12-week program and includes school, parent, and student components which are integrated via joint teacher, parent, and student meetings and use of integrated behavioral programs in the classroom, on the playground, and at home.

Outcomes

Primary Outcome Measures

Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMIV/V.

Secondary Outcome Measures

Homework Problems Checklist (HPC)

Academic Competency Evaluation Scale (ACES)

Homework Problems Checklist (HPC)

Academic Competency Evaluation Scale (ACES)

Children's Organizational Skills Scale (COSS)

Observations of classroom/school behavior

Academic achievement

Academic Achievement

Social Skills Improvement Scale

Test of Life Skills Knowledge

Alabama Parenting Questionnaire

Parenting Stress Index

Full Information

NCT ID

NCT01686724

First Posted

July 16, 2012

Last Updated

June 14, 2019

Sponsor

University of California, San Francisco

1. Study Identification

Unique Protocol Identification Number

NCT01686724

Brief Title

Study of the Collaborative Life Skills Program

Official Title

Efficacy of the Collaborative Life Skills Program

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

September 2012 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of California, San Francisco

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study tests the effectiveness of a newly developed integrated school-home behavioral intervention for behaviors related to Attention Deficit Hyperactivity Disorder (ADHD). The intervention is implemented by school-based mental health professionals within school settings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Attention Deficit Hyperactivity Disorder Symptoms

Keywords

Attention Deficit Hyperactivity Disorder, Psychosocial Intervention, Behavioral Intervention, School-home collaborative intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

504 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Business as Usual (BAU)

Arm Type

Other

Arm Description

This group receives services as usual in their schools. They will receive the intervention after follow-up measures are gathered.

Arm Title

Collaborative Life Skills Intervention (CLS)

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Collaborative Life Skills Intervention (CLS)

Intervention Description

Intervention Type

Other

Intervention Name(s)

Business As Usual

Primary Outcome Measure Information:

Title

Symptoms of Attention Deficit Hyperactivity Disorder as defined by DSMIV/V.

Time Frame

change from baseline on ADHD symptoms at 12 weeks

Secondary Outcome Measure Information:

Title

Homework Problems Checklist (HPC)

Time Frame

change from baseline in homework problems at 12 weeks

Title

Academic Competency Evaluation Scale (ACES)

Time Frame

change from baseline in ACES at 12 weeks

Title

Homework Problems Checklist (HPC)

Time Frame

change from baseline in homework problems at 7 months

Title

Academic Competency Evaluation Scale (ACES)

Time Frame

change from baseline in ACES at 7 months

Title

Children's Organizational Skills Scale (COSS)

Time Frame

change from baseline in COSS at 12 weeks

Title

Children's Organizational Skills Scale (COSS)

Time Frame

change from baseline in COSS at 7 months

Title

Observations of classroom/school behavior

Time Frame

change from baseline on observed on-task behavior at 12 weeks

Title

Observations of classroom/school behavior

Time Frame

change from baseline in observed on-task behavior at 7 months

Title

Academic achievement

Time Frame

change from baseline in academic achievement at 12 weeks

Title

Academic Achievement

Time Frame

change from baseline in academic achievement at 7 months

Title

Social Skills Improvement Scale

Time Frame

change from baseline in social/behavioral functioning at 12 weeks

Title

Social Skills Improvement Scale

Time Frame

change from baseline in social/behavioral functioning at 7 months

Title

Test of Life Skills Knowledge

Time Frame

change from baseline in life skills knowledge at 12 weeks

Title

Test of Life Skills Knowledge

Time Frame

change from baseline in life skills knowledge at 7 months

Title

Alabama Parenting Questionnaire

Time Frame

change from baseline in parenting practices at 12 weeks

Title

Alabama Parenting Questionnaire

Time Frame

change from baseline in parenting practices at 7 months

Title

Parenting Stress Index

Time Frame

change from baseline in parenting stress at 12 weeks

Title

Parenting Stress Index

Time Frame

change from baseline in parenting stress at 7 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Attending a participating school and in 2-5th grade Referral by LSP as a child with apparent ADHD-related problems ≥ 6 symptoms (item score ≥ 2) of Inattention or Hyperactivity-Impulsivity on the pooled parent and teacher Child Symptom Inventory ≥ 3 on the Impairment Rating Scale by parent and teacher (cross-situational impairment) FSIQ or VIQ ≥ 80 (necessary for cognitive demands of the child skills curriculum) Caretaker consents to participate in treatment, child assents to participate Exclusion Criteria: Presence of conditions that are incompatible with this study's treatment. severe visual or hearing impairment, severe language delay, psychosis, pervasive developmental disorder Parent or child does not read or speak English or does not read or speak Spanish for our Spanish language implementation of CLS (inability to complete assessment measures or participate in group treatments). Child is in an all-day special education classroom (children in these classrooms are frequently receiving intensive behavior modification programs such that the intervention would be expected to require modification for use in these settings) Children taking psychotropic medication for any reason other than to treat ADHD Children planning to change (start or stop) psychotropic medication Children who have changed a regimen of psychotropic medication (started or stopped) within 30 days prior to screening

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Linda Pfiffner, PhD

Organizational Affiliation

University of California, San Francisco

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of California San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29588050

Citation

Pfiffner LJ, Rooney ME, Jiang Y, Haack LM, Beaulieu A, McBurnett K. Sustained Effects of Collaborative School-Home Intervention for Attention-Deficit/Hyperactivity Disorder Symptoms and Impairment. J Am Acad Child Adolesc Psychiatry. 2018 Apr;57(4):245-251. doi: 10.1016/j.jaac.2018.01.016. Epub 2018 Feb 8.

Results Reference

derived

PubMed Identifier

27566117

Citation

Pfiffner LJ, Rooney M, Haack L, Villodas M, Delucchi K, McBurnett K. A Randomized Controlled Trial of a School-Implemented School-Home Intervention for Attention-Deficit/Hyperactivity Disorder Symptoms and Impairment. J Am Acad Child Adolesc Psychiatry. 2016 Sep;55(9):762-70. doi: 10.1016/j.jaac.2016.05.023. Epub 2016 Jul 1.

Results Reference

derived

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Study of the Collaborative Life Skills Program

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